Display of temporally aligned heart information from separate implantable medical devices on an extracorporeal display

ABSTRACT

A cardiac rhythm management system includes a first implantable device such as a defibrillator and a second implantable device such as a leadless cardiac pacemaker. A programmer is configured to receive and display heart data emanating from the implantable defibrillator and from the leadless cardiac pacemaker. The heart data emanating from the leadless cardiac pacemaker is displayed in temporal alignment with the heart data emanating from the implantable defibrillator.

This is a continuation of co-pending U.S. patent application Ser. No.14/835,250, filed Aug. 25, 2015, which claims the benefit of U.S.Provisional Patent Application Ser. No. 62/043,086 filed Aug. 28, 2014,both of which are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure generally relates to implantable medical devicesand more particularly to methods and systems for displaying informationfrom implantable medical devices on an extracorporeal display.

BACKGROUND

Pacing instruments can be used to treat patients suffering from variousheart conditions that may result in a reduced ability of the heart todeliver sufficient amounts of blood to a patient's body. These heartconditions may lead to rapid, irregular, and/or inefficient heartcontractions. To help alleviate some of these conditions, variousdevices (e.g., pacemakers, defibrillators, etc.) can be implanted in apatient's body. Such devices may monitor and provide electricalstimulation to the heart to help the heart operate in a more normal,efficient and/or safe manner. In some cases, a patient may have multipleimplanted devices that are configured to communicate information betweenthe devices. In some instances, such as during a physician visit, itwould be desirable to display temporally aligned heart information fromeach of the implantable devices on an extracorporeal display.

SUMMARY

The present disclosure generally relates to implantable medical devicesand more particularly to methods and systems for displaying temporallyaligned heart information from two or more implantable medical deviceson an extracorporeal display.

In a first example, a cardiac rhythm management system may include animplantable defibrillator configured to monitor a patient's heart andprovide shocking therapy if appropriate, and a leadless cardiacpacemaker configured to sense the patient's heart and provide pacingtherapy if appropriate. A programmer may be configured to receive anddisplay temporal heart data emanating from the implantable defibrillatorand from the leadless cardiac pacemaker. The temporal heart dataemanating from the leadless cardiac pacemaker may be displayed intemporal alignment with the heart data emanating from the implantabledefibrillator on the display of the programmer. In some cases, the heartdata emanating from the implantable defibrillator and the heart dataemanating from the leadless cardiac pacemaker each identify theoccurrence of one or more temporal events.

Alternatively, or additionally, and in a second example, the heart dataof the first example, emanating from the implantable defibrillatorand/or the leadless cardiac pacemaker, is displayed by the programmer inreal or near real time.

Alternatively, or additionally, and in a third example, the heart dataof the first example, emanating from the implantable defibrillatorand/or the leadless cardiac pacemaker, is stored data and the storeddata is displayed at a later time.

Alternatively, or additionally, and in a fourth example, the heart dataof any of the first through third examples, emanating from the leadlesscardiac pacemaker, is communicated to the programmer via the implantabledefibrillator.

Alternatively, or additionally, and in a fifth example, the heart dataof any of the first through fourth examples, emanating from theimplantable defibrillator, includes at least a portion of anelectrocardiogram.

Alternatively, or additionally, and in a sixth example, the heart dataof any of the first through fifth examples, emanating from the leadlesscardiac pacemaker, includes a plurality of markers.

Alternatively, or additionally, and in a seventh example, the heart dataof any of the first through sixth examples, emanating from theimplantable defibrillator, includes a number of first time stamps.

Alternatively, or additionally, and in an eighth example, the heart dataof any of the first through seventh examples, emanating from theleadless cardiac pacemaker, includes a number of second time stamps.

Alternatively, or additionally, and in a ninth example, the programmerof the eighth example is configured to use the first and second timestamps to temporally align the heart data emanating from the implantabledefibrillator and the heart data emanating from the leadless cardiacpacemaker.

Alternatively, or additionally, and in a tenth example, the programmerof any of the first through eighth examples in which the programmer isconfigured to utilize one or more user-defined time delay parameters totemporally align the heart data emanating from the implantabledefibrillator and the heart data emanating from the leadless cardiacpacemaker.

Example eleven is a cardiac rhythm management system including a firstimplantable device, a second implantable device and a programmer incommunication with the first implantable device and the secondimplantable device. In some embodiments, the first implantable devicemay be an implantable defibrillator and the second implantable devicemay be a leadless cardiac pacemaker as in examples one through ten, butthis is not required. The programmer is configured to receive anddisplay heart data collected by the first implantable device and heartdata collected by the second implantable device, wherein the heart datacollected by the first implantable device and the heart data collectedby the second implantable device each identify the occurrence of one ormore temporal events. The programmer displays the heart data collectedby the second device in temporal alignment with the heart data collectedby the first device.

Alternatively, or additionally, and in a twelfth example, the programmerof the eleventh example is further configured to display the heart datacollected by the first implantable device and the second implantabledevice in real or near real time.

Alternatively, or additionally, and in a thirteenth example, the heartdata of the eleventh example collected by the first implantable deviceand/or the heart data collected by the second implantable device isstored data, and the stored heart data collected by the firstimplantable device and/or the stored heart data collected by the secondimplantable device is displayed at a later time.

Alternatively, or additionally, and in a fourteenth example, the heartdata of any of the eleventh through thirteenth examples, collected bythe first implantable device, includes at least a portion of anelectrocardiogram.

Alternatively, or additionally, and in a fifteenth example, the heartdata of any of the eleventh through fourteenth example, collected by thesecond device, includes a plurality of markers.

Alternatively, or additionally, and in a sixteenth example, the heartdata of any of the eleventh through fifteenth examples, collected by thefirst implantable device and/or the second implantable device, includesa plurality of time stamps, and the programmer is configured to use theplurality of time stamps to temporally align the heart data collected bythe first implantable device and the heart data collected by the secondimplantable device.

Alternatively, or additionally, and in a seventeenth example, theprogrammer of any of the eleventh through fifteenth examples isconfigured to utilize one or more user-defined time delay parameters totemporally align the heart data collected by the first implantabledevice and the heart data collected by the second implantable device.

Example eighteen is a method of comparing heart rhythm data from aplurality of implantable medical devices. Heart data emanating from afirst implantable device that is configured to monitor a patient's heartis received. Heart data emanating from a second implantable device thatis configured to monitor the patient's heart is received. The heart dataemanating from the second implantable device is temporally offset fromthe heart data emanating from the first implantable device. The heartdata emanating from the first implantable device is temporally alignedwith the heart data emanating from the second implantable device and thetemporally aligned heart data is displayed on a display.

Alternatively, or additionally, and in a nineteenth example, in themethod of the eighteenth example, temporally aligning the heart dataemanating from the first implantable device with the heart dataemanating from the second implantable device includes using time stampdata included with either the heart data emanating from the firstimplantable device, the heart data emanating from the second implantabledevice, or both.

Alternatively, or additionally, and in a twentieth example, in themethod of any of the eighteenth or nineteenth examples, temporallyaligning the heart data emanating from the first implantable device withthe heart data emanating from the second implantable device includesusing a user-defined delay value for heart data emanating from thesecond implantable device.

Alternatively, or additionally, and in a twenty first example, in themethod of any of the eighteenth through twentieth examples in whichdisplaying the temporally aligned heart data includes displaying atleast a portion of an electrocardiogram emanating from the firstimplantable device and one or more markers emanating from the secondimplantable device.

The above summary is not intended to describe each embodiment or everyimplementation of the present disclosure. Advantages and attainments,together with a more complete understanding of the disclosure, willbecome apparent and appreciated by referring to the followingdescription and claims taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing description of various illustrative embodiments in connectionwith the accompanying drawings, in which:

FIG. 1 is a schematic block diagram of an illustrative leadless cardiacpacemaker (LCP) according to an example of the present disclosure;

FIG. 2 is a schematic block diagram of another illustrative medicaldevice that may be used in conjunction with the LCP of FIG. 1;

FIG. 3 is a schematic diagram of an exemplary medical system thatincludes multiple LCPs and/or other devices in communication with oneanother;

FIG. 4 is a schematic diagram of a system including an LCP and anothermedical device, in accordance with an example of the present disclosure;

FIG. 5 is a schematic diagram of a system including an LCP and anothermedical device, in accordance with an example of the present disclosure;

FIG. 6 is a schematic diagram of a system including a first implantabledevice and a second implantable device, according to an example of thepresent disclosure;

FIG. 7 is a diagram showing a display according to an example of thepresent disclosure;

FIG. 8 is a diagram showing a display according to an example of thepresent disclosure;

FIG. 9 is a diagram showing a display according to an example of thepresent disclosure;

FIG. 10 is a diagram showing a display according to an example of thepresent disclosure;

FIG. 11 is a diagram showing a display according to an example of thepresent disclosure; and

FIG. 12 is a flow diagram illustrating a method that may be carried outusing any of the systems of FIGS. 1-6.

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit aspects of thedisclosure to the particular illustrative embodiments described. On thecontrary, the intention is to cover all modifications, equivalents, andalternatives falling within the spirit and scope of the disclosure.

DESCRIPTION

The following description should be read with reference to the drawingsin which similar elements in different drawings are numbered the same.The description and the drawings, which are not necessarily to scale,depict illustrative embodiments and are not intended to limit the scopeof the disclosure.

A normal, healthy heart induces contraction by conducting intrinsicallygenerated electrical signals throughout the heart. These intrinsicsignals cause the muscle cells or tissue of the heart to contract. Thiscontraction forces blood out of and into the heart, providingcirculation of the blood throughout the rest of the body. However, manypatients suffer from cardiac conditions that affect this contractilityof their hearts. For example, some hearts may develop diseased tissuesthat no longer generate or conduct intrinsic electrical signals. In someexamples, diseased cardiac tissues conduct electrical signals atdiffering rates, thereby causing an unsynchronized and inefficientcontraction of the heart. In other examples, a heart may generateintrinsic signals at such a low rate that the heart rate becomesdangerously low. In still other examples, a heart may generateelectrical signals at an unusually high rate. In some cases such anabnormality can develop into a fibrillation state, where the contractionof the patient's heart chambers are almost completely de-synchronizedand the heart pumps very little to no blood. Implantable medical devicewhich may be configured to determine occurrences of such cardiacabnormalities or arrhythmias and deliver one or more types of electricalstimulation therapy to patient's hearts may help to terminate oralleviate such cardiac conditions.

FIG. 1 depicts an exemplary leadless cardiac pacemaker (LCP) that may beimplanted into a patient and may operate to prevent, control, orterminate cardiac arrhythmias in patients, for example by appropriatelyemploying one or more therapies (e.g. anti-tachycardia pacing (ATP)therapy, cardiac resynchronization therapy (CRT), bradycardia therapy,defibrillation pulses, or the like). As can be seen in FIG. 1, LCP 100may be a compact device with all components housed within LCP 100 ordirectly on housing 120. In the example shown in FIG. 1, LCP 100 mayinclude a communication module 102, a pulse generator module 104, anelectrical sensing module 106, a mechanical sensing module 108, aprocessing module 110, a battery 112, and electrodes 114. LCP 100 mayinclude more or less modules, depending on the application.

Communication module 102 may be configured to communicate with devicessuch as sensors, other medical devices, and/or the like, that arelocated externally to LCP 100. Such devices may be located eitherexternal or internal to the patient's body. Irrespective of thelocation, external devices (i.e. external to the LCP 100 but notnecessarily external to the patient's body) can communicate with LCP 100via communication module 102 to accomplish one or more desiredfunctions. For example, LCP 100 may communicate information, such assensed electrical signals, data, instructions, messages, etc., to anexternal medical device through communication module 102. The externalmedical device may use the communicated signals, data, instructionsand/or messages to perform various functions, such as determiningoccurrences of arrhythmias, delivering electrical stimulation therapy,storing received data, displaying received data, and/or performing anyother suitable function. LCP 100 may additionally receive informationsuch as signals, data, instructions and/or messages from the externalmedical device through communication module 102, and LCP 100 may use thereceived signals, data, instructions and/or messages to perform variousfunctions, such as determining occurrences of arrhythmias, deliveringelectrical stimulation therapy, storing received data, and/or performingany other suitable function. Communication module 102 may be configuredto use one or more methods for communicating with external devices. Forexample, communication module 102 may communicate via radiofrequency(RF) signals, inductive coupling, optical signals, acoustic signals,conducted communication signals, and/or any other signals suitable forcommunication.

In the example shown in FIG. 1, pulse generator module 104 may beelectrically connected to electrodes 114. In some examples, LCP 100 mayadditionally include electrodes 114′. In such examples, pulse generator104 may also be electrically connected to electrodes 114′. Pulsegenerator module 104 may be configured to generate electricalstimulation signals. For example, pulse generator module 104 maygenerate electrical stimulation signals by using energy stored inbattery 112 within LCP 100 and deliver the generated electricalstimulation signals via electrodes 114 and/or 114′. Alternatively, oradditionally, pulse generator 104 may include one or more capacitors,and pulse generator 104 may charge the one or more capacitors by drawingenergy from battery 112. Pulse generator 104 may then use the energy ofthe one or more capacitors to deliver the generated electricalstimulation signals via electrodes 114 and/or 114′. In at least someexamples, pulse generator 104 of LCP 100 may include switching circuitryto selectively connect one or more of electrodes 114 and/or 114′ topulse generator 104 in order to select which electrodes 114/114′ (and/orother electrodes) pulse generator 104 delivers the electricalstimulation therapy. Pulse generator module 104 may generate electricalstimulation signals with particular features or in particular sequencesin order to provide one or multiple of a number of different stimulationtherapies. For example, pulse generator module 104 may be configured togenerate electrical stimulation signals to provide electricalstimulation therapy to combat bradycardia, tachycardia, cardiacsynchronization, bradycardia arrhythmias, tachycardia arrhythmias,fibrillation arrhythmias, cardiac synchronization arrhythmias and/or toproduce any other suitable electrical stimulation therapy. Some morecommon electrical stimulation therapies include anti-tachycardia pacing(ATP) therapy, cardiac resynchronization therapy (CRT), andcardioversion/defibrillation therapy.

In some examples, LCP 100 may not include a pulse generator 104. Forexample, LCP 100 may be a diagnostic only device. In such examples, LCP100 may not deliver electrical stimulation therapy to a patient. Rather,LCP 100 may collect data about cardiac electrical activity and/orphysiological parameters of the patient and communicate such data and/ordeterminations to one or more other medical devices via communicationmodule 102.

In some examples, LCP 100 may include an electrical sensing module 106,and in some cases, a mechanical sensing module 108. Electrical sensingmodule 106 may be configured to sense the cardiac electrical activity ofthe heart. For example, electrical sensing module 106 may be connectedto electrodes 114/114′, and electrical sensing module 106 may beconfigured to receive cardiac electrical signals conducted throughelectrodes 114/114′. The cardiac electrical signals may represent localinformation from the chamber in which LCP 100 is implanted. Forinstance, if LCP 100 is implanted within a ventricle of the heart,cardiac electrical signals sensed by LCP 100 through electrodes 114/114′may represent ventricular cardiac electrical signals. Mechanical sensingmodule 108 may include one or more sensors, such as an accelerometer, ablood pressure sensor, a heart sound sensor, a blood-oxygen sensor, atemperature sensor, a flow sensor and/or any other suitable sensors thatare configured to measure one or more mechanical/chemical parameters ofthe patient. Both electrical sensing module 106 and mechanical sensingmodule 108 may be connected to a processing module 110, which mayprovide signals representative of the sensed mechanical parameters.Although described with respect to FIG. 1 as separate sensing modules,in some cases, electrical sensing module 106 and mechanical sensingmodule 108 may be combined into a single sensing module, as desired. Inaddition to, or instead of, electrical sensing module 106 and/ormechanical sensing module 108, LCP 100 may include other types ofsensing modules such as a magnetic sensing module, a chemical sensingmodule and/or a nuclear sensing module.

Electrodes 114/114′ can be secured relative to housing 120 but exposedto the tissue and/or blood surrounding LCP 100. In some cases,electrodes 114 may be generally disposed on either end of LCP 100 andmay be in electrical communication with one or more of modules 102, 104,106, 108, and 110. Electrodes 114/114′ may be supported by the housing120, although in some examples, electrodes 114/114′ may be connected tohousing 120 through short connecting wires such that electrodes 114/114′are not directly secured relative to housing 120. In examples where LCP100 includes one or more electrodes 114′, electrodes 114′ may in somecases be disposed on the sides of LCP 100, which may increase the numberof electrodes by which LCP 100 may sense cardiac electrical activity,deliver electrical stimulation and/or communicate with an externalmedical device. Electrodes 114/114′ can be made up of one or morebiocompatible conductive materials such as various metals or alloys thatare known to be safe for implantation within a human body. In someinstances, electrodes 114/114′ connected to LCP 100 may have aninsulative portion that electrically isolates electrodes 114/114′ fromadjacent electrodes, housing 120, and/or other parts of the LCP 100.

Processing module 110 can be configured to control the operation of LCP100. For example, processing module 110 may be configured to receiveelectrical signals from electrical sensing module 106 and/or mechanicalsensing module 108. Based on the received signals, processing module 110may determine, for example, occurrences and, in some cases, types ofarrhythmias. Based on any determined arrhythmias, processing module 110may control pulse generator module 104 to generate electricalstimulation in accordance with one or more therapies to treat thedetermined arrhythmia(s). Processing module 110 may further receiveinformation from communication module 102. In some examples, processingmodule 110 may use such received information to help determine whetheran arrhythmia is occurring, determine a type of arrhythmia, and/or totake particular action in response to the information. Processing module110 may additionally control communication module 102 to send/receiveinformation to/from other devices.

In some examples, processing module 110 may include a pre-programmedchip, such as a very-large-scale integration (VLSI) chip and/or anapplication specific integrated circuit (ASIC). In such embodiments, thechip may be pre-programmed with control logic in order to control theoperation of LCP 100. By using a pre-programmed chip, processing module110 may use less power than other programmable circuits (e.g. generalpurpose programmable microprocessors) while still being able to maintainbasic functionality, thereby potentially increasing the battery life ofLCP 100. In other examples, processing module 110 may include aprogrammable microprocessor. Such a programmable microprocessor mayallow a user to modify the control logic of LCP 100 even afterimplantation, thereby allowing for greater flexibility of LCP 100 thanwhen using a pre-programmed ASIC. In some examples, processing module110 may further include a memory, and processing module 110 may storeinformation on and read information from the memory. In other examples,LCP 100 may include a separate memory (not shown) that is incommunication with processing module 110, such that processing module110 may read and write information to and from the separate memory.

Battery 112 may provide power to the LCP 100 for its operations. In someexamples, battery 112 may be a non-rechargeable lithium-based battery.In other examples, a non-rechargeable battery may be made from othersuitable materials, as desired. Because LCP 100 is an implantabledevice, access to LCP 100 may be limited after implantation.Accordingly, it is desirable to have sufficient battery capacity todeliver therapy over a period of treatment such as days, weeks, months,years or even decades. In some instances, battery 112 may a rechargeablebattery, which may help increase the useable lifespan of LCP 100. Instill other examples, battery 112 may be some other type of powersource, as desired.

To implant LCP 100 inside a patient's body, an operator (e.g., aphysician, clinician, etc.), may fix LCP 100 to the cardiac tissue ofthe patient's heart. To facilitate fixation, LCP 100 may include one ormore anchors 116. Anchor 116 may include any one of a number of fixationor anchoring mechanisms. For example, anchor 116 may include one or morepins, staples, threads, screws, helix, tines, and/or the like. In someexamples, although not shown, anchor 116 may include threads on itsexternal surface that may run along at least a partial length of anchor116. The threads may provide friction between the cardiac tissue and theanchor to help fix the anchor 116 within the cardiac tissue. In otherexamples, anchor 116 may include other structures such as barbs, spikes,or the like to facilitate engagement with the surrounding cardiactissue.

FIG. 2 depicts an example of another medical device (MD) 200, which maybe used in conjunction with LCP 100 (FIG. 1) in order to detect and/ortreat cardiac arrhythmias and other heart conditions. In the exampleshown, MD 200 may include a communication module 202, a pulse generatormodule 204, an electrical sensing module 206, a mechanical sensingmodule 208, a processing module 210, and a battery 218. Each of thesemodules may be similar to modules 102, 104, 106, 108, and 110 of LCP100. Additionally, battery 218 may be similar to battery 112 of LCP 100.In some examples, however, MD 200 may have a larger volume withinhousing 220. In such examples, MD 200 may include a larger batteryand/or a larger processing module 210 capable of handling more complexoperations than processing module 110 of LCP 100.

While it is contemplated that MD 200 may be another leadless device suchas shown in FIG. 1, in some instances MD 200 may include leads such asleads 212. Leads 212 may include electrical wires that conductelectrical signals between electrodes 214, housing 220, and/or one ormore modules located within housing 220. In some cases, leads 212 may beconnected to and extend away from housing 220 of MD 200. In someexamples, leads 212 are implanted on, within, or adjacent to a heart ofa patient. Leads 212 may contain one or more electrodes 214 positionedat various locations on leads 212, and in some cases at variousdistances from housing 220. Some leads 212 may only include a singleelectrode 214, while other leads 212 may include multiple electrodes214. Generally, electrodes 214 are positioned on leads 212 such thatwhen leads 212 are implanted within the patient, one or more of theelectrodes 214 are positioned to perform a desired function. In somecases, the one or more of the electrodes 214 may be in contact with thepatient's cardiac tissue. In some cases, the one or more of theelectrodes 214 may be positioned subcutaneously but adjacent thepatient's heart. In some cases, electrodes 214 may conduct intrinsicallygenerated electrical signals to leads 212, e.g. signals representativeof intrinsic cardiac electrical activity. Leads 212 may, in turn,conduct the received electrical signals to one or more of the modules202, 204, 206, and 208 of MD 200. In some cases, MD 200 may generateelectrical stimulation signals, and leads 212 may conduct the generatedelectrical stimulation signals to electrodes 214. Electrodes 214 maythen conduct the electrical signals and delivery the signals to thepatient's heart (either directly or indirectly).

Mechanical sensing module 208, as with mechanical sensing module 108,may contain or be electrically connected to one or more sensors, such asaccelerometers, blood pressure sensors, heart sound sensors,blood-oxygen sensors, and/or other sensors which are configured tomeasure one or more mechanical/chemical parameters of the heart and/orpatient. In some examples, one or more of the sensors may be located onleads 212, but this is not required. In some examples, one or more ofthe sensors may be located in or on housing 220.

While not required, in some examples, MD 200 may be an implantablemedical device. In such examples, housing 220 of MD 200 may be implantedin, for example, a transthoracic region of the patient. Housing 220 maygenerally include any of a number of known materials that are safe forimplantation in a human body and may, when implanted, hermetically sealthe various components of MD 200 from fluids and tissues of thepatient's body.

In some cases, MD 200 may be an implantable cardiac pacemaker (ICP). Inthis example, MD 200 may have one or more leads, for example leads 212,which are implanted on or within the patient's heart. The one or moreleads 212 may include one or more electrodes 214 that are in contactwith cardiac tissue and/or blood within the patient's heart. MD 200 maybe configured to sense intrinsically generated cardiac electricalsignals and determine, for example, one or more cardiac arrhythmiasbased on analysis of the sensed signals. MD 200 may be configured todeliver CRT, ATP therapy, bradycardia therapy, and/or other therapytypes via leads 212 implanted within the heart. In some examples, MD 200may additionally be configured provide defibrillation therapy.

In some instances, MD 200 may be an implantablecardioverter-defibrillator (ICD). In such examples, MD 200 may includeone or more leads implanted within a patient's heart. MD 200 may also beconfigured to sense cardiac electrical signals, determine occurrences oftachyarrhythmias based on the sensed signals, and may be configured todeliver defibrillation therapy in response to determining an occurrenceof a tachyarrhythmia. In other examples, MD 200 may be a subcutaneousimplantable cardioverter-defibrillator (S-ICD). In examples where MD 200is an S-ICD, one of leads 212 may be a subcutaneously implanted lead. Inat least some examples where MD 200 is an S-ICD, MD 200 may include onlya single lead which is implanted subcutaneously, but this is notrequired.

In some examples, MD 200 may not be an implantable medical device.Rather, MD 200 may be a device external to the patient's body, and mayinclude skin-electrodes that are placed on a patient's body. In suchexamples, MD 200 may be able to sense surface electrical signals (e.g.cardiac electrical signals that are generated by the heart or electricalsignals generated by a device implanted within a patient's body andconducted through the body to the skin). In such examples, MD 200 may beconfigured to deliver various types of electrical stimulation therapy,including, for example, defibrillation therapy.

FIG. 3 illustrates an example of a medical device system and acommunication pathway through which multiple medical devices 302, 304,306, and/or 310 may communicate. In the example shown, medical devicesystem 300 may include LCPs 302 and 304, external medical device 306,and other sensors/devices 310. External device 306 may be any of thedevices described previously with respect to MD 200. Othersensors/devices 310 may also be any of the devices described previouslywith respect to MD 200. In some instances, other sensors/devices 310 mayinclude a sensor, such as an accelerometer or blood pressure sensor, orthe like. In some cases, other sensors/devices 310 may include anexternal programmer device that may be used to program one or moredevices of system 300.

Various devices of system 300 may communicate via communication pathway308. For example, LCPs 302 and/or 304 may sense intrinsic cardiacelectrical signals and may communicate such signals to one or more otherdevices 302/304, 306, and 310 of system 300 via communication pathway308. In one example, one or more of devices 302/304 may receive suchsignals and, based on the received signals, determine an occurrence ofan arrhythmia. In some cases, device or devices 302/304 may communicatesuch determinations to one or more other devices 306 and 310 of system300. In some cases, one or more of devices 302/304, 306, and 310 ofsystem 300 may take action based on the communicated determination of anarrhythmia, such as by delivering a suitable electrical stimulation tothe heart of the patient. It is contemplated that communication pathway308 may communicate using RF signals, inductive coupling, opticalsignals, acoustic signals, or any other signals suitable forcommunication. Additionally, in at least some examples, devicecommunication pathway 308 may comprise multiple signal types. Forinstance, other sensors/device 310 may communicate with external device306 using a first signal type (e.g. RF communication) but communicatewith LCPs 302/304 using a second signal type (e.g. conductedcommunication). Further, in some examples, communication between devicesmay be limited. For instance, as described above, in some examples, LCPs302/304 may communicate with external device 306 only through othersensors/devices 310, where LCPs 302/304 send signals to othersensors/devices 310, and other sensors/devices 310 relay the receivedsignals to external device 306.

In some cases, communication pathway 308 may include conductedcommunication. Accordingly, devices of system 300 may have componentsthat allow for such conducted communication. For instance, the devicesof system 300 may be configured to transmit conducted communicationsignals (e.g. current and/or voltage pulses) into the patient's body viaone or more electrodes of a transmitting device, and may receive theconducted communication signals (e.g. pulses) via one or more electrodesof a receiving device. The patient's body may “conduct” the conductedcommunication signals (e.g. pulses) from the one or more electrodes ofthe transmitting device to the electrodes of the receiving device in thesystem 300. In such examples, the delivered conducted communicationsignals (e.g. pulses) may differ from pacing or other therapy signals.For example, the devices of system 300 may deliver electricalcommunication pulses at an amplitude/pulse width that is sub-thresholdto the heart. Although, in some cases, the amplitude/pulse width of thedelivered electrical communication pulses may be above the capturethreshold of the heart, but may be delivered during a refractory periodof the heart and/or may be incorporated in or modulated onto a pacingpulse, if desired.

In some cases, communication pathway 308 may function solely as acommunication pathway. In other cases, communication pathway 308 mayalso perform sensing and/or therapy functions.

Delivered electrical communication pulses may be modulated in anysuitable manner to encode communicated information. In some cases, thecommunication pulses may be pulse width modulated or amplitudemodulated. Alternatively, or in addition, the time between pulses may bemodulated to encode desired information. In some cases, conductedcommunication pulses may be voltage pulses, current pulses, biphasicvoltage pulses, biphasic current pulses, or any other suitableelectrical pulse as desired.

FIGS. 4 and 5 show illustrative medical device systems that may beconfigured to operate according to techniques disclosed herein. In FIG.4, an LCP 402 is shown fixed to the interior of the left ventricle ofthe heart 410, and a pulse generator 406 is shown coupled to a lead 412having one or more electrodes 408 a-408 c. In some cases, the pulsegenerator 406 may be part of a subcutaneous implantablecardioverter-defibrillator (S-ICD), and the one or more electrodes 408a-408 c may be positioned subcutaneously adjacent the heart. In somecases, the LCP 402 may communicate with the subcutaneous implantablecardioverter-defibrillator (S-ICD). In some cases, the LCP 402 may be inthe right ventricle, right atrium or left atrium of the heart, asdesired. In some cases, more than one LCP 402 may be implanted. Forexample, one LCP may be implanted in the right ventricle and another maybe implanted in the right atrium. In another example, one LCP may beimplanted in the right ventricle and another may be implanted in theleft ventricle. In yet another example, one LCP may be implanted in eachof the chambers of the heart. In a further example, one or more LCPs maybe implanted on an interior wall of the heart and one or more LCPs maybe implanted on an exterior wall of the heart.

In FIG. 5, an LCP 502 is shown fixed to the interior of the leftventricle of the heart 510, and a pulse generator 506 is shown coupledto a lead 512 having one or more electrodes 504 a-504 c. In some cases,the pulse generator 506 may be part of an implantable cardiac pacemaker(ICP) and/or an implantable cardioverter-defibrillator (ICD), and theone or more electrodes 504 a-504 c may be positioned in the heart 510.In some cases, the LCP 502 may communicate with the implantable cardiacpacemaker (ICP) and/or an implantable cardioverter-defibrillator (ICD).

The medical device systems 400 and 500 may also include an externalsupport device, such as external support devices 420 and 520. Externalsupport devices 420 and 520 can be used to perform functions such asdevice identification, device programming and/or transfer of real-timeand/or stored data between devices using one or more of thecommunication techniques described herein. As one example, communicationbetween external support device 420 and the pulse generator 406 isperformed via a wireless mode, and communication between the pulsegenerator 406 and LCP 402 is performed via a conducted mode. In someexamples, communication between the LCP 402 and external support device420 is accomplished by sending communication information through thepulse generator 406. However, in other examples, communication betweenthe LCP 402 and external support device 420 may be via a communicationmodule.

FIGS. 4-5 only illustrate two examples of medical device systems thatmay be configured to operate according to techniques disclosed herein.Other example medical device systems may include additional or differentmedical devices and/or configurations. For instance, other medicaldevice systems that are suitable to operate according to techniquesdisclosed herein may include additional LCPs implanted within the heart.Another example medical device system may include a plurality of LCPswithout other devices such as pulse generator 406 or 506, with at leastone LCP capable of delivering defibrillation therapy. In yet otherexamples, the configuration or placement of the medical devices, leads,and/or electrodes may be different from those depicted in FIGS. 6 and 7.Accordingly, it should be recognized that numerous other medical devicesystems, different from those depicted in FIGS. 4 and 5, may be operatedin accordance with techniques disclosed herein. As such, the examplesshown in FIGS. 4 and 5 should not be viewed as limiting in any way.

It will be appreciated that the implantable devices described herein,including but not limited to LCP 100, MD 200, LCP 302, LCP 304, LCP 402,pulse generator 406, LCP 502 and pulse generator 506 may collect datapertaining to the patient's heart beat and rhythm. In some instances, itmay be desirable to display this data, either real-time or later, foranalysis and comparison. As illustrated for example with respect toFIGS. 3-5, these devices may be in different positions relative to eachother and relative to the patient's heart. As a result, in some casesthese devices may see a particular cardiac event from a differentrelative position and thus may see a particular cardiac event asoccurring at a slightly different time. Accordingly, in some cases thecardiac event data from a first device may be temporally shiftedrelative to the cardiac event data (pertaining to the same event) from asecond device. Moreover, one implantable device may “see” an event orsignal with more specificity and clarity than another implantabledevice. For example, an LCP that is implanted with the heart itself maysense cardiac signals with more specificity and clarity than an SICDdevice that has subcutaneous sense electrodes that are positionedoutside of the chest cavity. In this example, the LCP may sense the nearfield of the cardiac signal, while the SICD may sense the far field.

FIG. 6 is a schematic diagram of a system 600 that includes a firstimplantable device 602, a second implantable device 604 and a programmer606. While identified as a programmer, element 606 may also beconsidered as being any of a non-implanted device, extracorporeal deviceor a non-implanted monitoring device. In some embodiments, a programmeror other non-implanted device may, for example, including a processorfor processing data, memory for storing data and instructions,input/output devices for receiving and sharing data and otheroperational parameters, and the like. In some cases, a programmer orother non-implanted device may be included as part of a remote patientdata monitoring system.

First implantable device 602 may be any implantable device, includingthose described with respect to FIGS. 1-5. Second implantable device 604may be any implantable device, including those described with respect toFIGS. 1-5. In some embodiments, first implantable device 602 is animplantable defibrillator and second implantable device 604 is aleadless cardiac pacemaker, but this is not required. In someembodiments, programmer 606 is configured to communicate with firstimplantable device 602 and/or second implantable device 604. A varietyof information may be communicated between programmer 606 and firstimplantable device 602 and/or between programmer 606 and secondimplantable device 604. In some embodiments, first implantable device602 communicates directly with programmer 606 and second implantabledevice 604 communicates directly with programmer 606. In some instances,first implantable device 602 communicates directly with programmer 606while second implantable device 604 communicates indirectly withprogrammer 606 through first implantable device 602. In someembodiments, first implantable device 602 may communicate directly withsecond implantable device 604. In some embodiments, first implantabledevice 602 and second implantable device 604 communicate indirectly witheach other through programmer 606. In some instances, first implantabledevice 602 and second implantable device 604 do not communicate witheach other.

In the example shown, programmer 606 includes a display 608. While avariety of different information may be displayed on display 608, itwill be appreciated that temporal heart data emanating from firstimplantable device 602 and/or heart data emanating from secondimplantable device 604 may be temporally displayed on display 608. Insome embodiments, the heart data emanating from first implantable device602 is temporally shifted with respect to the heart data emanating fromsecond implantable device 604. In some embodiments, the heart dataemanating from first implantable device 602 may be displayed on display608 in temporal alignment with the heart data emanating from secondimplantable device 604. In some embodiments, the heart data from each offirst implantable device 602 and second implantable device 604identifies the occurrence of one or more temporal events.

In some embodiments, programmer 606 is configured to display the heartdata emanating from first implantable device 602 and second implantabledevice 604 in real or near real time. In this, real time may be definedas instantaneous with an event, or within several milliseconds after theevent. Near real time may be defined as ranging from severalmilliseconds after the event to perhaps 10 or 20 milliseconds after theevent. In some cases, the heart data emanating from first implantabledevice 602 and/or the heart data emanating from second implantabledevice 604 is stored data, and the stored heart data emanating fromfirst implantable device 602 and/or the stored heart data emanating fromsecond implantable device 604 is displayed at a later time. The heartdata emanating from first implantable device 602 may, in some cases,include at least a portion of an electrocardiogram while the heart dataemanating from second implantable device 604 may, in some cases, includea plurality of markers (sometimes without an electrocardiogram). Theplurality of markers may include any number of markers including, forexample, bradycardia/pacing markers and tachycardia/shocking markers.

Examples of bradycardia/pacing markers include VS (VentricularSense—After Refractory), [VS] (Ventricular Sense—Noise First Trigger),VS-Hy (Ventricular Sense—At Hysteresis Rate), VP (Ventricular Pace—LowerRate or Atrial Tracked), VP↓ (Ventricular Pace—Rate Smoothing Down), VP↑(Ventricular Pace—Rate Smoothing Up), VP-FB (Ventricular Pace—Fallback),VP-Hy (Ventricular Pace—At Hysteresis Rate), VP-Sr (VentricularPace—Sensor Rate), VP-Ns (Ventricular Pace—Noise) VP-Tr (VentricularPace—Trigger Mode) and VP-VR (Ventricular Pace—Ventricular RateRegulation).

Examples of tachycardia/shock markers include PVC (PVC AfterRefractory), VT-1 (VT-1 Zone Sense), VT (VT Zone Sense), VF (VF ZoneSense), V-Epsd (Ventricular Tachy Start Episode), V-EpsdEnd (VentricularTachy End Episode), AFibV (V AFib Criteria Met), V-Dur (Duration Met),V-Detect (Ventricular Detection Met), Chrg (Start/End Charge), Dvrt(Therapy Diverted), Shock (Shock Delivered) and SRD (Sustained RateDuration Expired).

Programmer 606 may temporally align the data from first implantabledevice 602 and second implantable device 604 in any suitable manner. Insome embodiments, it is one of first implantable device 602 and secondimplantable device 604 that receives and temporally aligns its data withdata received from the other of first implantable device 602 and secondimplantable device 604, then transmits the temporally aligned data toprogrammer 606 for display.

In some embodiments, for example, the heart data emanating from firstimplantable device 602 and/or the heart data emanating from secondimplantable device 604 includes a plurality of time stamps, andprogrammer 606 may be configured to use the plurality of time stamps totemporally align the heart data emanating from first implantable device602 and the heart data emanating from second implantable device 604. Insome embodiments, data emanating from first implantable device 602 mayinclude a number of first time stamps, and data emanating from secondimplantable device 604 may include a number of second time stamps.Programmer 606 may utilize this number of first time stamps and numberof second time stamps to temporally align the heart data.

In some embodiments, programmer 606 is configured to utilize one or moreuser-defined time delay parameters to temporally align the heart dataemanating from first implantable device 602 and the heart data emanatingfrom second implantable device 604. For example, there may be aconsistent delay or time shift between data from first implantabledevice 602 and data from second implantable device 604, due for exampleto relative positions of first implantable device 602 and secondimplantable device 604, and/or due perhaps to communication delaysbetween devices. In some cases, a user-defined time delay parameter maybe inputted into programmer 606, which can then use the time delayparameter to help temporally align the heart data.

In some cases, the programmer 606 aligns the heart data. In otherinstances, the second implantable device 604 may receive heart data fromthe first implantable device 602 and then temporally align the heartdata of the first implantable device 602 with the heart data of thesecond implantable device 604. The temporally aligned data may then becommunicated from the second implantable device 604 to the programmer,wherein the temporally aligned data may be aligned with further heartdata collected by the programmer if any, and displayed on a display ofthe programmer.

In some cases, the aligned data is displayed, stored and/or printed on aprogrammer. In other cases, the aligned data is displayed, stored and/orprinted in a system that is remote from the patient, such as a remotepatient management system. In some embodiments, the aligned data isdisplayed, stored and/or printed on a device used by the patient in ahome or other non-clinical setting. While not programmers, these otherdevices may be used to display, store and/or print aligned data.

FIGS. 7 through 11 provide examples of heart data that may be displayedvia display 608 of programmer 606. FIG. 7 provides a display 700 ofindividual leadless cardiac pacemaker (LCP) markers. Display 700 may beseen as including several sense events, denoted with a marker “S”, and apace event, denoted with a marker “P”. FIG. 8 provides a display 800 ofan SICD egram of the same cardiac events shown in FIG. 7. Display 800may be seen as including several sense events, denoted with a marker“S”. Several points of interest in display 800 include an errant senseevent, in which a T-wave is incorrectly read by the SICD as being asense event (e.g. due to far field sensing of the SICD). Another pointof interest is that the pace event detected by the LCP is interpreted bythe SICD as a sense event.

FIG. 9 provides a display 900 that includes a combination of display 700and display 800, with the heart data from the LCP (markers) temporallyaligned with the heart data (electrocardiogram) from the SICD. It can beseen that the first sense event detected by the LCP temporally alignswith the first sense event detected by the SICD. By comparing the datafrom both devices on a single display, a physician or other professionalcan see that the later sense event detected by the SICD was actually apace event as detected (and initiated) by the LCP. FIG. 10 is similar,but provides a display 1000 that shows an electrocardiogram and markersfrom the LCP compared with markers from the SICD. FIG. 11 provides adisplay 1100 that compares an electrocardiogram and markers from the LCPwith an electrocardiogram and markers from the SICD.

It can be seen that display 608 may be used to display a variety ofheart data emanating from first implantable device 602 and secondimplantable device 604. While data from two devices is illustrated, itwill be appreciated that programmer 606 may be configured to temporallyalign and display heart data from any number of implantable devices,either in real-time or later displaying stored data.

In some cases, the aligned data relates to electrocardiograms andcardiac pace/sense markers. In other cases, the aligned data relates toother data acquired by implantable device 602 and/or implantable device604. Examples of other data include markers for cardiac arrhythmias,markers for shock therapy or other markers indicating patient or deviceevent. Yet other data may include trended data for cardiac conditions(e.g., atrial fibrillation, hypertension), pulmonary conditions (e.g.,asthma), renal conditions (e.g., diabetes) or other patient conditions.Still other data may include data related to neural stimulation therapy,pharmaceutical therapy, and respiratory therapy (e.g., continuouspositive airway pressure, CPAP).

FIG. 12 is a flow diagram showing an illustrative method that may becarried out using the systems described herein. At block 1202, dataemanating from a first implantable device configured to monitor apatient is received. In some embodiments, the data is heart data, butthis is not required. Data emanating from a second implantable devicethat is configured to monitor the patient is received, as generallyindicated at block 1204. The data (such as heart data) emanating fromthe second implantable device is temporally offset from the data (suchas heart data) emanating from the first implantable device. In someembodiments, the first implantable device may be first implantabledevice 602 and the second implantable device may be second implantabledevice 604, but this is not required.

At block 1206, the data (such as heart data) emanating from the firstimplantable device is temporally aligned with the data (such as heartdata) emanating from the second implantable device. In some embodiments,temporally aligning the data (such as heart data) emanating from thefirst implantable device with the data (such as heart data) emanatingfrom the second implantable device includes using time stamp dataincluded with either the data emanating from the first implantabledevice, the data emanating from the second implantable device, or both.In some embodiments, temporally aligning the data emanating from thefirst implantable device with the data emanating from the secondimplantable device includes using a user-defined delay value for dataemanating from the second implantable device.

The temporally aligned data (such as heart data) is displayed on anextracorporeal display as generally indicated at block 1208. In someembodiments, displaying the temporally aligned data includes displayingat least a portion of an electrocardiogram emanating from the firstimplantable device, and simultaneously displaying one or more markersemanating from the second implantable device (sometimes without anelectrocardiogram emanating from the second implantable device). In someembodiments, additional data may also be displayed.

Those skilled in the art will recognize that the present disclosure maybe manifested in a variety of forms other than the specific examplesdescribed and contemplated herein. For instance, as described herein,various examples include one or more modules described as performingvarious functions. However, other examples may include additionalmodules that split the described functions up over more modules thanthat described herein. Additionally, other examples may consolidate thedescribed functions into fewer modules. Accordingly, departure in formand detail may be made without departing from the scope and spirit ofthe present disclosure as described in the appended claims.

What is claimed is:
 1. A cardiac rhythm management system comprising: animplantable defibrillator configured to sense cardiac activity of apatient's heart and provide shocking therapy if appropriate, theimplantable defibrillator configured generate an electrocardiogram usingthe sensed cardiac activity; a leadless cardiac pacemaker configured tosense the cardiac activity of the patient's heart and provide pacingtherapy if appropriate, the leadless cardiac pacemaker furtherconfigured to generate a plurality of cardiac markers using the sensedcardiac activity and to transmit the plurality of cardiac markers; theimplantable defibrillator further configured to: receive the pluralityof cardiac markers from the leadless cardiac pacemaker; and transmit theelectrocardiogram and the plurality of cardiac markers; and anon-implanted device configured to receive the electrocardiogram and theplurality of cardiac markers from the implantable defibrillator, and todisplay the electrocardiogram and the plurality of cardiac markers intemporal alignment so that the plurality of cardiac markers generated bythe leadless cardiac pacemaker may be used to help verify one or morefeatures of the electrocardiogram generated by the implantabledefibrillator.
 2. The cardiac rhythm management system of claim 1,wherein the implantable defibrillator is further configured to:temporally align the plurality of cardiac markers received from theleadless cardiac pacemaker with the electrocardiogram generated by theimplantable defibrillator; and transmit the electrocardiogram and thetemporally aligned plurality of cardiac markers for reception by thenon-implanted device.
 3. The cardiac rhythm management system of claim2, wherein the implantable defibrillator is configured to use one ormore user-defined time delay parameters to temporally align theplurality of cardiac markers received from the leadless cardiacpacemaker with the electrocardiogram generated by the implantabledefibrillator.
 4. The cardiac rhythm management system of claim 2,wherein the non-implanted device is configured receive and display theelectrocardiogram and the temporally aligned plurality of cardiacmarkers on a display.
 5. The cardiac rhythm management system of claim1, wherein the non-implanted device is configured to: temporally alignthe plurality of cardiac markers generated by the leadless cardiacpacemaker with the electrocardiogram generated by the implantabledefibrillator; and display the electrocardiogram and the temporallyaligned plurality of cardiac markers on a display.
 6. The cardiac rhythmmanagement system of claim 5, wherein the non-implanted device isconfigured to use one or more user-defined time delay parameters totemporally align the plurality of cardiac markers generated by theleadless cardiac pacemaker with the electrocardiogram generated by theimplantable defibrillator.
 7. The cardiac rhythm management system ofclaim 1, wherein the non-implanted device is configured to display theelectrocardiogram and the plurality of temporally aligned cardiacmarkers in real or near real time.
 8. The cardiac rhythm managementsystem of claim 1, wherein the implantable defibrillator is configuredto store the electrocardiogram in real or near real time and transmitthe electrocardiogram at a later time.
 9. The cardiac rhythm managementsystem of claim 8, wherein the implantable defibrillator is configuredto store the plurality of cardiac markers in real or near real time andtransmit the plurality of cardiac markers at a later time.
 10. Thecardiac rhythm management system of claim 1, wherein the leadlesscardiac pacemaker is configured to store the plurality of cardiacmarkers in real or near real time and transmit the plurality of cardiacmarkers at a later time.
 11. The cardiac rhythm management system ofclaim 1, wherein the electrocardiogram generated by the implantabledefibrillator includes a plurality of time stamps temporally alignedwith the electrocardiogram.
 12. The cardiac rhythm management system ofclaim 9, wherein the plurality of cardiac markers generated by theleadless cardiac pacemaker includes a plurality of time stampstemporally aligned with the plurality of cardiac markers.
 13. Thecardiac rhythm management system of claim 10, wherein the plurality oftime stamps temporally aligned with the electrocardiogram and theplurality of time stamps temporally aligned with the plurality ofcardiac markers are used to display the electrocardiogram and theplurality of cardiac markers in temporal alignment.
 14. A cardiac rhythmmanagement system comprising: a first implantable device configured tosense cardiac activity of a patient's heart and to generate anelectrocardiogram using the sensed cardiac activity; a secondimplantable device configured to sense the cardiac activity of thepatient's heart, generate a plurality of cardiac markers using thesensed cardiac activity, and transmit the plurality of cardiac markers;the first implantable device further configured to: receive theplurality of cardiac markers from the second implantable device;transmit the electrocardiogram and the plurality of cardiac markers; anda non-implanted device configured to receive and to display theelectrocardiogram and the plurality of cardiac markers in temporalalignment so that the plurality of cardiac markers generated by thesecond implantable device may be used to help verify one or morefeatures of the electrocardiogram generated by the first implantabledevice.
 15. The cardiac rhythm management system of claim 14, whereinthe first implantable device is further configured to: temporally alignthe plurality of cardiac markers received from the second implantabledevice with the electrocardiogram generated by the first implantabledevice; and transmit the electrocardiogram and the temporally alignedplurality of cardiac markers for reception by the non-implanted device.16. The cardiac rhythm management system of claim 15, wherein thenon-implanted device is configured receive and display theelectrocardiogram and the temporally aligned plurality of cardiacmarkers on a display.
 17. The cardiac rhythm management system of claim14, wherein the non-implanted device is configured to: temporally alignthe plurality of cardiac markers received from the second implantabledevice with the electrocardiogram generated by the first implantabledevice; and display the electrocardiogram and the temporally alignedplurality of cardiac markers on a display.
 18. The cardiac rhythmmanagement system of claim 14, wherein the non-implanted device isconfigured to display the electrocardiogram and the plurality oftemporally aligned cardiac markers in real or near real time.
 19. Thecardiac rhythm management system of claim 14, wherein the firstimplantable device is configured to store the electrocardiogram in realor near real time and transmit the electrocardiogram at a later time.20. A cardiac rhythm management system comprising: a first implantabledevice configured to sense cardiac activity of a patient's heart and togenerate a first representation of cardiac events using the sensedcardiac activity; a second implantable device configured to sense thecardiac activity of the patient's heart, generate a secondrepresentation of cardiac events using the sensed cardiac activity, andtransmit the second representation of cardiac events; the firstimplantable device further configured to: receive the secondrepresentation of cardiac events from the second implantable device;transmit the first representation of cardiac events and the secondrepresentation of cardiac events; and a non-implanted device configuredto receive and to display the first representation of cardiac events andthe second representation of cardiac events in temporal alignment witheach other.